Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-02-25 @ 7:20 PM
Study NCT ID:
NCT01944293
Status:
COMPLETED
Last Update Posted:
2020-03-11
First Post:
2013-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ketamine for Suicidality in Bipolar Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}, {'id': 'D013405', 'term': 'Suicide'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.grunebaum@nyspi.columbia.edu', 'phone': '646-774-7573', 'title': 'Michael Grunebaum, MD', 'organization': 'Columbia University Medical Center - NY State Psychiatric Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Ketamine', 'description': '0.5 mg/kg, I.V. (in the vein)\n\nKetamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Midazolam', 'description': '0.02 mg/kg, I.V. (in the vein)\n\nKetamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes\n\nMidazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Increased suicidal thoughts requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Preparatory suicidal behavior', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Suicidal Ideation Measured With the Beck Scale for Suicidal Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': '0.5 mg/kg, I.V. (in the vein)\n\nKetamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes'}, {'id': 'OG001', 'title': 'Midazolam', 'description': '0.02 mg/kg, I.V. (in the vein)\n\nKetamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes\n\nMidazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.4', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '7.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 24 hours post-Infusion', 'description': 'Change in suicidal ideation in Bipolar Disorder during a Major Depressive Episode (MDE), with moderate to severe suicidal thoughts, from the pre-infusion baseline to 24 hours after the infusion of Ketamine (study drug) or Midazolam (active control).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Bipolar depression with suicidal ideation.'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine', 'description': '0.5 mg/kg, I.V. (in the vein)\n\nKetamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes'}, {'id': 'OG001', 'title': 'Midazolam', 'description': '0.02 mg/kg, I.V. (in the vein)\n\nKetamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes\n\nMidazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '3', 'spread': '10.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During study infusion', 'description': 'Blood pressure is measured in millimeters of mercury.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketamine', 'description': '0.5 mg/kg, I.V. (in the vein)\n\nKetamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes'}, {'id': 'FG001', 'title': 'Midazolam', 'description': '0.02 mg/kg, I.V. (in the vein)\n\nKetamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes\n\nMidazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketamine', 'description': '0.5 mg/kg, I.V. (in the vein)\n\nKetamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes'}, {'id': 'BG001', 'title': 'Midazolam', 'description': '0.02 mg/kg, I.V. (in the vein)\n\nKetamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes\n\nMidazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '43', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '40.5', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'More than one race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White race', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race/Ethnicity, Customized: Non-white', 'unitOfMeasure': 'Participants'}, {'title': 'Beck Scale for Suicidal Ideation (Clinician-rated)', 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '16.8', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '16.8', 'spread': '6.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This scale has 19 items scaled 0 (least severe) to 2 (most severe) with a potential score total range of 0 to 38 measuring severity of suicidal thoughts.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-14', 'size': 245390, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-14T12:58', 'hasProtocol': False}, {'date': '2019-07-01', 'size': 557107, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-27T14:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2013-09-08', 'resultsFirstSubmitDate': '2018-10-03', 'studyFirstSubmitQcDate': '2013-09-12', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-14', 'studyFirstPostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Suicidal Ideation Measured With the Beck Scale for Suicidal Ideation', 'timeFrame': 'At 24 hours post-Infusion', 'description': 'Change in suicidal ideation in Bipolar Disorder during a Major Depressive Episode (MDE), with moderate to severe suicidal thoughts, from the pre-infusion baseline to 24 hours after the infusion of Ketamine (study drug) or Midazolam (active control).'}], 'secondaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'During study infusion', 'description': 'Blood pressure is measured in millimeters of mercury.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ketamine', 'Midazolam', 'Bipolar Disorder', 'Major Depressive Episode', 'Suicidal Ideation', 'Suicide', 'Depression', 'Treatment', 'Ketamine Treatment'], 'conditions': ['Bipolar Disorder', 'Major Depressive Episode', 'Suicidal Ideation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.columbiapsychiatry.org/mind/', 'label': 'MIND Clinic for Mood and Personality Disorders'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar depression.\n\nThe first drug, ketamine, is an experimental antidepressant that early studies have shown may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the comparison drug, is not thought to reduce depression or suicidal thoughts.', 'detailedDescription': 'Patients currently taking psychiatric medications may continue them during the study. However, if a patient is taking a benzodiazepine (such as Ativan, Klonopin, or Xanax), they will be able to take up to 2mg per day of Lorazepam during the week before the infusion, but none will be permitted in the 24 hours pre-infusion. Also, Zolpidem (Ambien) will not be permitted in the 24 hours pre-infusion. If a person chooses to participate, their dose of benzodiazepine may need to be reduced so that they can do without it during the 24 hours pre-infusion.\n\nParticipants are randomly assigned to receive a single dose of Ketamine (0.5 mg/kg) or Midazolam (0.02 mg/kg), which is given slowly, in a vein, over about 40 minutes. The study is "double-blind," meaning patients and study staff will not know which medication is in the infusion.\n\nIf a patient does not respond to the first infusion, and s/he received Midazolam, then s/he will be offered the option of a second infusion, this time with Ketamine (0.5 mg/kg). After the infusion(s), participants will have weekly research interviews for 6 weeks to monitor response.\n\nAfter post-infusion research measures are completed, all subjects will receive open clinical treatment. During open clinical treatment, medication will be changed for those patients who don\'t respond or whose response is transient.\n\nParticipation in this study requires a brief inpatient stay, at no cost, at the New York State Psychiatric Institute (NYSPI).\n\nEligible participants enrolled in this study will be offered medication management visits at no cost for a total of up to 6 months combining inpatient and outpatient treatment. At the end of the 6 months of treatment patients will be referred for ongoing care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Bipolar depression with current major depressive episode (MDE). Participants may be psychiatric medication-free, or if on psychiatric medication, not responding adequately given current MDE with suicidal ideation.\n* Moderate to severe suicidal ideation\n* 18-65 years old\n* Patients will only be enrolled if they agree to voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for infusion phase of treatment.\n* Pre-menopausal female participants of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, oral contraceptive pills\n* Able to provide informed consent\n* Subjects 61-65 years old must score 25 or higher on the Mini-Mental State Examination (MMSE) at screening\n\nEXCLUSION CRITERIA:\n\n* Unstable medical condition or neurological illness, including baseline hypertension (BP\\>140/90) or significant history of cardiovascular illness\n* Significant ECG abnormality\n* Pregnancy and/or lactation\n* Current psychotic symptoms\n* Contraindication to any study treatment\n* Current or past ketamine abuse or dependence ever (lifetime); any other drug or alcohol dependence within past 6 months; suicidality only due to binge substance use or withdrawal\n* Inadequate understanding of English\n* Prior ineffective trial of or adverse reaction to ketamine or midazolam\n* Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3 days pre-infusion'}, 'identificationModule': {'nctId': 'NCT01944293', 'briefTitle': 'Ketamine for Suicidality in Bipolar Depression', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Ketamine vs. Midazolam in Bipolar Depression', 'orgStudyIdInfo': {'id': '#6785'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine', 'description': '0.5 mg/kg, I.V. (in the vein)', 'interventionNames': ['Drug: Ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'description': '0.02 mg/kg, I.V. (in the vein)', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Ketalar', 'Ketamine Hydrochloride Injection'], 'description': 'Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes', 'armGroupLabels': ['Ketamine']}, {'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Midazolam Injection'], 'description': 'Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes', 'armGroupLabels': ['Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University/New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Michael F Grunebaum, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia Unviversity/New York State Psychiatric Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brain & Behavior Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychiatrist', 'investigatorFullName': 'Michael Grunebaum, MD', 'investigatorAffiliation': 'New York State Psychiatric Institute'}}}}